A pragmatic single-blind randomised controlled trial and health economic evaluation of leukotriene receptor antagonists in primary care at steps two and three of the national asthma guidelines
| ISRCTN | ISRCTN99132811 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99132811 |
| Secondary identifying numbers | HTA 98/34/05 |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 11/10/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof David Price
Scientific
Scientific
Department of General Practice & Primary Care
University of Aberdeen
Foresterhill Health Centre
Westburn Road
Aberdeen
AB25 2AY
United Kingdom
| Phone | +44 (0)1224 554588 |
|---|---|
| david@respiratoryresearch.org |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | ELEVATE |
| Study objectives | This study will evaluate the relative clinical effectiveness and costs at time points over a two year follow-up (short-term specifically at two months and long-term over two years) of Leukotriene Receptor Antagonist (LTRA) prescription in primary care. PRIMARY: To compare quality of life with LTRAs against alternative treatments at steps two and three of the guidelines, comparing resource use over a two year period to the NHS and patients (on an intention to treat basis), using either a cost-minimisation or cost-effectiveness approach. The choice will depend on whether differences emerge between the groups over two years with particular emphasis on two months and two years (i.e. short and long-term). SECONDARY: To compare other clinically relevant asthma outcomes between two treatment groups at two months and throughout the two year study (see Primary outcomes). The design enables this to be compared at step two with inhaled steroid prescription and at step three with add-on of a long-acting beta agonist prescription. Its pragmatic design coupled with clinical trial rigour: 1. Concealed randomised allocation of patients, 2. Blinded procedures for recording and collection of outcomes data (by a non-clinician) and blinded data analysis should produce results that are both valid and applicable to primary care as a whole. Please note that, as of 25 January 2008, the start and end dates of this trial were updated from 1 January 2000 and 30 April 2003 to 1 October 2001 and 28 February 2007, respectively. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Asthma |
| Intervention | LTRAs versus alternative treatment |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Leukotriene receptor antagonist |
| Primary outcome measure | 1. Need for further treatment intervention 2. Frequency of exacerbations 3. Short-acting beta agonist use 4. Hospitalisations 5. Time off work 6. Daily inhaled steroid dose (step three) 7. Asthma symptoms 8. Morning and diurnal variation in peak flow 9. Those with eczema/rhinitis comparative change in disease assessment |
| Secondary outcome measures | Not provided at time of registration. |
| Overall study start date | 01/10/2001 |
| Completion date | 28/02/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 720 |
| Key inclusion criteria | Not provided at time of registration. |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/10/2001 |
| Date of final enrolment | 28/02/2007 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Department of General Practice & Primary Care
Aberdeen
AB25 2AY
United Kingdom
AB25 2AY
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Phone | +44 (0)1132 545 843 |
|---|---|
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
"ROR" |
https://ror.org/03sbpja79 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Beta-2 results | 01/10/2010 | Yes | No | |
| Results article | Corticosteroid results | 01/10/2010 | Yes | No | |
| Results article | results | 01/05/2011 | Yes | No | |
| Results article | results | 05/05/2011 | Yes | No |
